Efficacy of L-PRF Against Deproteinized Bovine Mineralized Bone (DBBM)
- Conditions
- Patients with Posterior Maxillary Atrophy and Need for Sinus Lift Surgery to Allow Implant Placement
- Registration Number
- NCT06686836
- Lead Sponsor
- University of Santiago de Compostela
- Brief Summary
Objective: The main objective of this study is to evaluate whether the use of L-PRF combined with deproteinized bovine mineralized bone (DBBM; BioOss, Geistlich Pharma®) reduces healing time, through histomorphometric analysis using bone biopsies after maxillary sinus elevation versus the use of deproteinized bovine mineralized bone (DBBM) alone.
Materials and methods: 24 patients with posterior maxillary atrophy (residual bone height \<5mm without need for vertical regeneration) and need for sinus lift surgery to allow implant placement were treated ,12 DBBM (control group) 12 L-PRF block (Test group). At 4 months after sinus lift, a biopsy was taken and implants were placed with submerged healing. After 6 months, the second surgical phase was performed and another biopsy was taken. The bone samples collected were analyzed histologically and histomorphometrically. Patients received prosthetic restorations after 9 months and were followed up at 12 months. Volumetric changes were analyzed at 4 and 12 months.
- Detailed Description
The study was a double-blind randomized controlled clinical trial (RCT), with a parallel design. Patients requiring an open sinus lift procedure before implant placement.
For the procedure it was use two types of filler, L-PRF block (test group) and DBBM alone (control group).
All patients were randomized and assigned to each of the study groups through a computer-generated randomization.
The primary outcome was percentage of new bone formed after treatment by histological and histomorphometric measurement of biopsies (%NeoformedBone=(Regenerated bone/total area)x100) at 4 and 6 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- Patients >18 years
- Presence of oral health (periodontally healthy or periodontitis treated), with a BoP <20% and PI <20%.
- Systemically healthy, with no disease that might contraindicate oral surgery.
- Non-smokers or smokers of <10 cig/day.
- Need to place implants in postero-superior sector with a residual bone height of < 5mm (no need for vertical regeneration).
- More than 3 months since tooth extraction in the treatment area.
- Absence of sinus pathology.
- Patients who, due to systemic conditions, blood extraction is not possible.
- Medication that may interfere with bone metabolism (e.g. corticosteroids, bisphosphonates).
- History of radiotherapy.
- Pregnant and/or breastfeeding women.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Percentage of new bone formed 4 and 6 months after treatment Measured by histological and histomorphometric analysis of biopsies at 4 and 6 months after sinus lift surgery
- Secondary Outcome Measures
Name Time Method Percentage of remaining material (%) 4 and 6 months after treatment Measured by histology analysis at 4 and 6 months;
Volumetric changes of regenerated bone baseline, 4 and 12 months after treatment Measured in millimeters according to CBCT at 4 and 12 months after maxillary sinus lift in apico-coronal and bucco-lingual orientation
Implant stability 4 and 6 months after treatment Mesured ISQ (\>65N) at the time of implant placement and in the second surgical phase before connecting the abutment to the implant).
Implant success 12 months after treatment According to the criteria described by Misch,2008
Trial Locations
- Locations (1)
Department of periodontology, Faculty of Dentistry, University of Santiago de Compostela
🇪🇸Santiago de Compostela, Spain